Dianette co-cyprindiol Clairette

Mission: APRIL has campaigned to improve the warnings on patient information leaflets supplied to users of this drug and that doctors should be warned to be alert to Dianette-induced depression. We know from the women who contact us that the drug is being over prescribed and for far too long without warnings of the risk of thrombosis and psychiatric side effects. In many cases women have been prescribed antidepressants while not being warned Dianette may be the cause of their low mood or other psychiatric changes.

Treats: Acne, hirsuitism, and also acts as oral contraceptive, though not licensed for this.

Side effects: Increased risk of Deep Vein Thrombosis and Depression.

Please see our short film on YouTube over 15,000 people have viewed the video. The EU review is over now and some countries have restricted the use of Dianette. Information about informing the EU Medicines Agency is out of date but the balance of data is relevant.

Thank you to all the women and a couple of men who sent information to us about adverse reactions and enabled us to use this data in influencing the MHRA to ask the manufacturers to make it clear the drug CAUSES depression and related problems. Not all manufacturers have included this in the patient information however. If you have suffered changes you believe are caused by a pharmaceutical drug, please complain to the MHRA or send emails to us and we will forward the information. (link to Yellow Card system)

Summary

Dianette is licensed for the treatment of severe acne, which is unresponsive to prolonged antibiotic therapy, and moderately severe hirsutism (abnormal hair growth).

It also acts as an oral contraceptive, but it should not be used solely for this purpose and is not licensed for this use, due to concerns by medicines regulators of possible harms when used long term.

Depression is a known side effect of Dianette and the product information contains warnings on this issue.

The European Medicines Agency (EMA) has designated the drug in 2013 with a Black Triangle(link to info)allocated to drugs under intensive monitoring for side effects.

Psychiatric side-effects of Dianette

Depression is a known side effect of Dianette and the product information contains warnings on this issue.

The updated Patient Information Leaflet (PIL) states:

"Although, it is not considered a direct side effect of Dianette, some women have reported feeling depressed whilst taking Dianette. In very rare cases this has been associated with thoughts of ending their lives. If you develop severe depression, you should stop Dianette as a precaution, and see your doctor straight away."

A letter to APRIL dated ? from the MHRA stated

The description of psychiatric reactions in the product information for healthcare professionals and patients is currently being reviewed by the MHRA and the findings will be presented to the Medicines for Women’s Health Expert Advisory Group of the Commission on Human Medicines in the near future. The product information (including the patient information leaflet) will be updated if necessary.

Evidence

A poster presentation by APRIL at the 2011 conference to launch results of a review of the way patient reporting using the Yellow Card System had impacted on highlighting signals of previously unrecorded adverse drug reactions (ADRs). Following the announcement by the MHRA they would review the safety of Dianette and subsequent press coverage, more prescribers and women are aware of the risks associated with this drug.

Reports of adverse drug reactions (ADRs) may be sent to the Medicines Healthcare Products Regulatory Agency via the Yellow Card system you may download a reporting app or call them to explain or to request for them to send a paper form if you do not want to report on line.

Published to January 2017 on the MHRA Drug Analysis Print section of their website: Dianette stats were listed under Cyproterone

These included up to October 2014 (current analysis more difficult due to changes to DAP presentation on the MHRA web site:

54 reports of suicidal and self-injurious behaviour

52 reports of anxiety

175 reports of depression

Advice to patients and prescribers

Patients who have concerns about Dianette should discuss the matter with their pharmacist or doctor at a routine appointment. If as many women described “The cloud lifts” when you cease taking Dianette, this is a good signal the drug affected your moods.

Patients may also report suspected adverse reactions (ADRs) direct to the regulator the MHRA at www.yellowcard.gov.uk or by calling 0808 100 3352 between 10 - 2pm only.

Many deaths are not reported to the regulator as Coroners who are often not medically trained, are often unaware of the iatrogenic (treatment induced) link to deaths including suicides.

Suicides are also under reported and APRIL has received emails from women who attempted suicide or self harmed, they believe, due to the adverse reactions to Dianette.

DIANETTE is now being closely monitored and is a BLACK TRIANGLE drugWhat BLACK TRIANGLE means:

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to the medicines regutory agency – the MHRA now under auspices of the EU Medicines Agency

In The News

Ban of Dianette in France - Jan 2013

Dianette - known as Diane 35 in France, was temporarily suspended earlier last year by the European Medicines Agency (EMA) due to the blood clot deaths in Europe. Please also be aware a stroke may be caused by a blood clot and we have heard of women who believe a stroke they suffered was caused by Dianette or an oral contraceptive. There are links below to details of the EMA Inquiry into Dianette.

Medicines and Healthcare Products Regulatory Agency - MHRA

We have been in correspondence for many years with the MHR, including directly with their Director Dr June Raine, who finally conceded there may be a problem about depression links to Dianette and lack of awareness. However our request for a warning about this and the dvt risk to be sent to doctors was not heeded. We had concerns that so many women who contacted us had not been warned of either risk and many had been taking Dianette for some years, as many as 10- 15 years in some cases.

In spite of assurances by senior management in the MHRA that depression is considered by them to be a serious side effect, the review of Dianette led to no action in warning doctors to stop prescribing antidepressants to young women before assessing the cause of their mood swings or depression.. The MHRA also failed in their promise to put the result of their Dianette review on the MHRA website.

The warning on the Summary of Product Characteristics (SPC) which should be read by health professionals, mentions post marketing reports of depression. However the Patient Information Leaflet (PIL) still lists depression and loss of interest in sex as MILD side effects.

Reporting Adverse Drug Reactions (ADRs)

If you have suffered from depression or know of anyone who became seriously ill or died while taking Dianette, Diane 35, Ginette 35 or Clairette, please inform the regulator and contact APRIL.

CPA is marketed under brand names including Androcur, Androcur Depot, Androcur-100, Androstat, Asoteron, Cyprone, Cyproplex, Cyprostat, Cysaxal, Imvel, and Siterone. When CPA is formulated in combination with EE, it is also known as co-cyprindiol, and brand names for this formulation include Andro-Diane, Bella HEXAL 35, Chloe, Cypretil, Cypretyl, Cyproderm, Diane, Diane Mite, Diane-35, Dianette, Dixi 35, Drina, Elleacnelle, Estelle, Estelle-35, Ginette, Linface, Minerva, Vreya, and Zyrona.CPA is also marketed in combination with estradiol valerate as Climen, Climene, Elamax, and Femilar.

Availability

CPA is widely available throughout the world and is marketed in almost every country,with the notable major exception of the United States.The drug is marketed both alone and in combination with EE or estradiol valerate.Specific places in which CPA is marketed include the United Kingdom, other European countries, Canada, Australia, New Zealand, South Africa, Central and South America, and East and Southeast Asia.